| CTRI Number |
CTRI/2024/11/076284 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic Management In The Treatment Of Obesity In Children |
|
Scientific Title of Study
|
Efficacy Of Individualized Homoeopathic Medicines And Nutrition With Management For Obesity Among Children Aged 5-16 Years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karuna Priya CD |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
7339029141 |
| Fax |
|
| Email |
karunapriya1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Rathinasabapathi |
| Designation |
Head Of Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9842765594 |
| Fax |
|
| Email |
drersaba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Rathinasabapathi |
| Designation |
Head Of Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9842765594 |
| Fax |
|
| Email |
drersaba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Vinayaka Missions Homoeopathic Medical College And Hospital Nh47 Sankari Main
Road Seeragapadi Salem Tamilnadu 636308 India |
|
|
Primary Sponsor
|
| Name |
Karuna Priya CD |
| Address |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi Salem
TAMIL NADU 636308 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karuna Priya |
Vinayaka Missions Homoeopathic Medical College And Hospital |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi Salem
TAMIL NADU 636308 India
Salem
TAMIL NADU |
7339029141
karunapriya1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee vinayaka missions kirupananda variyar medical college and hospital salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diet therapy with general management |
Diet therapy with management is a significant approach for obesity especially in children. It helps with the proper growth and nourishment of the children and prevents serious health complications. Duration: Advice given for the patients 15 days once and follow up is monitoried |
| Intervention |
Individualized homoeopathic remedy along with diet therapy and management |
Homeopathic medicines are
selected based on the individualization of the patient. Based on the susceptibility of the patient the dose is selected. Medicine is administered via the oral route. One dose of medicine is administered orally at the start of treatment and follow-up is taken 15 days once. The medicine is repeated until the symptoms last and the follow-up is taken for nine months to evaluate the result of treatment. Along with homeopathic medicines diet therapy and management will be given. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group 5 - 16 years,
Children both male and female.
Children fulfilling the criteria of obesity based on the WHO Growth standard chart (Greater than 2 standard deviations from the WHO Growth Reference median) |
|
| ExclusionCriteria |
| Details |
Children who are underweight or malnourished (Lesser then 2 standard deviation from the WHO Growth reference median).
Children suffering from severe chronic and congenital illness.
Children under any chronic medications. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WHO Growth Standard Chart |
At the baseline and the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that the proposed study Will be useful in reducing the symptoms and severity of Obesity using Individualized medicines in the paediatric age group |
At the baseline and the end of the study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Efficacy Of Individualized Homoeopathic Medicines In Treating Obesity Has Been noted in Literary books such as Materia medica,the homoeopathic pharmacopia of india, and repertory; nevertheless clinical provings for obesity among children is less,which highlights the need for further research. An exploratory clinical study is carried out taking into account the active principles,phytochemical property , and symptoms gathered during drug proving regarding obesity in children. |